Motorized Orthosis for Lower Limb Injury

Overseen By Kate Goworek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Hypertension, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a motor-powered ankle foot orthosis (AFO) in improving comfort and convenience when walking after a lower limb injury. Participants will use the AFO to assess its impact on mobility. Individuals who sustained a lower limb injury over a year ago and can stand for 30 minutes may be suitable candidates. The goal is to ease walking for those who meet these criteria. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future mobility solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this motorized orthosis is safe for adults with lower limb injury?

Research has shown that a motorized brace can help people with leg injuries walk better. However, safety remains crucial. In some studies, individuals with spinal cord injuries using similar devices experienced serious problems, such as broken bones. These cases highlight the potential risks of using such devices. Each person's experience may vary, so discussing any potential risks with a healthcare provider before joining the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for lower limb injuries, which often include physical therapy and passive orthoses, the motorized orthosis is an active device that provides powered assistance to the user's movements. This technology is exciting because it potentially enhances mobility and accelerates rehabilitation by actively supporting and augmenting the natural movement of the leg. Researchers are particularly interested in how this approach can offer more dynamic support and adaptation to the user's needs compared to static braces or supports.

What evidence suggests that this motorized orthosis is effective for lower limb injury?

Research has shown that motorized braces can significantly enhance walking ability in individuals with leg injuries. Studies have found that powered exoskeletons, devices worn to assist movement, can make walking about 35% easier compared to regular braces. This improvement means people might use less energy when walking. Additionally, early reports suggest these devices can aid recovery, helping individuals regain strength and movement in their legs. Overall, these findings indicate that motorized braces could be a promising option for those with leg injuries. Participants in this trial will use a motorized orthosis to evaluate its effectiveness in improving mobility and recovery. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who have experienced a lower limb injury, such as a sprained ankle. The study aims to include individuals who can benefit from using an assistive walking device.

Inclusion Criteria

Be willing and able to give informed consent

I injured my leg over a year ago.

I can follow the study's procedures and instructions.

Exclusion Criteria

Have medical issues that affect the unaffected side

Have any other medical conditions that doctor or physical therapist feels would affect ability to use the device

I have joint or muscle tightness that limits my walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week rehabilitation program using a motor powered ankle foot orthosis (AFO) brace

6 weeks

Visits before and after the intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motorized Orthosis

Trial Overview The focus of the trial is on evaluating how effective and user-friendly a motorized ankle foot orthosis (AFO) brace is in improving walking ability after sustaining a lower limb injury.

How Is the Trial Designed?

Group I: Adults with lower limb injury Experimental Treatment 1 Intervention

All enrolled subjects will be asked to complete the intervention.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Stevens Institute of Technology

Collaborator

Trials

5

Recruited

8,700+

Published Research Related to This Trial

Two cases of bone fractures were reported during the use of powered robotic exoskeletons in patients with spinal cord injury, highlighting the potential risks associated with unexpected technical failures.

Proper alignment of the exoskeleton with the user's body is crucial to minimize fracture risks, and additional safety training is recommended for both patients and instructors to handle emergency situations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. van Herpen, FHM., van Dijsseldonk, RB., Rijken, H., et al.[2023]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Powered gait orthoses effectively induce movement in the lower limb joints of individuals with spinal cord injuries, improving walking mechanics and reducing strain on upper body muscles during ambulation.

While these devices enhance gait parameters, the impact on muscle activity remains uncertain, indicating a need for further research to optimize their design and functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of powered orthoses on walking in persons with paraplegia. Arazpour, M., Hutchins, SW., Ahmadi Bani, M.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3375739/

A Powered Lower Limb Orthosis for Providing Legged ... This paper presents preliminary results on the development of a powered lower limb orthosis intended to provide legged mobility (with the use of a stability aid ...

2. withpower.com withpower.com/trial/phase-leg-injuries-5-2025-653cf

Motorized Orthosis for Lower Limb Injury The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636223000656

Effects of Lower Limb Exoskeleton Gait Orthosis Compared ... This systematic review compared walking efficiency of patients with spinal cord injury wearing powered exoskeleton gait orthosis and non-powered mechanical ...

4. nature.com nature.com/articles/s41598-022-23556-4

Comparing walking with knee-ankle-foot orthoses and a ... We found that previous studies reported, on average, that walking with the (hip-knee-powered) exoskeletons was 35% more efficient (i.e., ...

5. pubs.aip.org pubs.aip.org/aip/rsi/article/94/4/041501/2884721/Application-of-robotic-lower-limb-orthosis-for

Application of robotic lower limb orthosis for people with ... According to current research, the use of RLLOs provides an effective means of rehabilitation for patients with lower-limb disorders. RLLO ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1414628/

Powered lower limb orthoses for gait rehabilitation - PMC The most extensive study published to date found that 80% of wheelchair bound patients with chronic incomplete spinal cord injury gained functional walking ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138321006288

IDEO energy-storing orthosis: Effects on lower extremity ... We identified 213 patients with 222 lower extremities treated with IDEO brace. Of these, 76 limbs were treated for combat-related injuries. At one year follow- ...

8. nature.com nature.com/articles/sc201639

Investigating the status of using lower extremity orthoses ... The present study aimed to investigate the rate of using orthosis among spinal cord injury (SCI) patients for whom orthosis was recommended for standing and ...